Summary

The Curetis Unyvero LRT55 Application is intended to detect and to identify genes of 21
microorganisms and 19 genes associated with antibiotic resistance in 4 hours.

In this study, the performance of the Unyvero LRT55 Application shall be tested under
clinical conditions and compared to (1) a composite reference method (for non-atypical or
cultured microorganisms) or (2) a molecular PCR based reference method for the 3 atypical
microorganisms Chlamydophila pneumoniae, Legionella pneumoniae, and Pneumocystis jirovecii,
and for resistance genes.

PCR amplifications are followed by bi-directional sequencing, including comparison of the
test results Time to result will be compared for the Unyvero LRT55 Application and
standard-of care.

Study Design

Patients with suspicion of lower respiratory tract infection (pneumonia), samples tested with Unyvero LRT 55 cartridge and results compared against composite (comparator) which is based on routine clinical microbiology and a second PCR test

Additional Information

This is a non-interventional, controlled, non-randomized multicenter clinical study that
compares a new diagnostic device, the Unyvero LRT55 Application (based on molecular
diagnostic methods) to either (1) a composite reference method (for non-atypical
microorganisms), (2) a composite PCR-based method for 3 atypical microorganisms or (3) a
PCR-based reference method for resistance genes.
The study will use leftover lower respiratory tract samples taken from subjects suspected
with lower respiratory tract infections: (a) Specimens taken prospectively for
standard-of-care (i.e. microbiology testing) from hospitalized subjects. (b) Banked
specimens for rare microorganisms.
As the device is under investigation, the test results provided by the Unyvero LRT55
Application will not be made available to the treating physician and therefore will not be
used for diagnosis, treatment or other management decisions.

Trial information was received from ClinicalTrials.gov and was last updated in November 2016.